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FAQs
bHIV is an estimate of HIV incidence in populations enrolled in the study if they were not on PrEP. bHIV was used as a comparator in lieu of a placebo arm for ethical reasons. See more about the innovative study design of YEZTUGO.
PURPOSE 1 included cisgender adolescent girls and young women aged 16 to 25 years with likelihood of acquiring HIV (had sexual encounters with male partners without recent HIV testing and had unknown HIV status) and were not on PrEP.1,3
PURPOSE 2 included cisgender men, transgender women, transgender men, and nonbinary individuals aged 16+ years with likelihood of acquiring HIV (had condomless sex with male partners, no recent HIV testing, and had unknown HIV status) and were not on PrEP.2,3
At the time of the primary analysis, there were 2 incident HIV infections among participants in the YEZTUGO arm, both with N74D resistance-associated capsid substitutions. This resistance-associated substitution does not impact DHHS-recommended initial regimens for HIV treatment, which typically include a combination of INSTI with NRTI.
On Day 1 of initiation, you’ll give the individual 2 injections into the appropriate injection sites and 2 YEZTUGO tablets for them to take that day in your office, then 2 tablets to be taken at home the next day.
The continuation dosing is 2 injections every 6 months from the date of the last injection, unless the injection schedule is interrupted. Review dosing.
The protocol varies depending on whether there are delayed or missed doses. See dosing details.
YEZTUGO comes as a vial and must be drawn into the provided syringes before injection in office. See administration details.
There are no specific requirements to rotate injection sites every 6 months, but each of the 2 injections must be at least 4 inches apart. The administrator may determine which injection sites are clinically appropriate. See administration details.
Yes. Gilead offers daily PrEP options. Explore one option here.
DHHS=US Department of Health and Human Services; INSTI=integrase strand transfer inhibitor; NRTI=nucleoside/nucleotide reverse transcriptase inhibitor.
References:
- Bekker LG, Das M, Abdool Karim Q, et al; PURPOSE 1 study team. Twice-yearly lenacapavir or daily F/TAF for HIV prevention in cisgender women. N Engl J Med. 2024;391(13):1179-1192.
- Kelley CF, Acevedo-Quiñones M, Agwu AL, et al; PURPOSE 2 study team. Twice-yearly lenacapavir for HIV prevention in men and gender-diverse persons. N Engl J Med. 2025;392(13):1261-1276.
- YEZTUGO. Prescribing information. Gilead Sciences, Inc.; 2025.
- Department of Health and Human Services. Guidelines for use of antiretroviral agents in adults and adolescents with HIV. Clinical info. Updated September 12, 2024. Accessed May 13, 2025. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf